PCV13 + Hepatitis a Vaccine for Adults (PCV13+HepA)

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Measurement of Immune Response to Prevenar13; Measurement of Immune Response to Hepatitis a

Treatments: Biological: Hepatitis A vaccine; Biological: Prevenar13

Study type: Interventional

Funder types: Other

Identifiers

NCT01926860

PCV13 adults + Hep A

Details and patient eligibility

About

The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control groups of adults receiving either hepatitis A or PCV13 vaccines only.

Enrollment: 305 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged ≥50
2. General good health as established by medical history and physical examination
3. Written informed consent
4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
5. Available for all visits scheduled in this study.
6. No previous Pnc vaccination
7. No previous hepatitis A vaccine
8. No other vaccines administered 30 days prior to or during the study

Exclusion criteria

1. Previous pneumococcal or hepatitis A vaccination
2. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
3. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of vaccine; patients using oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
5. Pregnancy or lactation
6. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C).
7. Alcohol or drug abuse
8. Suspected non-compliance
9. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
10. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
11. Employee at the investigational site, relative or spouse of the investigator
12. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 3 patient groups

Study group - Prevenar®13 and Hepatitis A vaccines

Experimental group

Description:

Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0

Treatment:

Biological: Prevenar13

Biological: Hepatitis A vaccine

Pneumococcal conjugate vaccine -Control group - Prevenar®13

Active Comparator group

Description:

PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0

Treatment:

Biological: Prevenar13

HepA -Control group - Hepatitis A vaccine

Active Comparator group

Description:

HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0

Treatment:

Biological: Hepatitis A vaccine